Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome

Summary

Low fermentable oligo-, di- and monosaccharides and polyols (FODMAPs) diet is taken as a possible strategy to improve symptoms in IBS patients. However, the gut-brain signalling mechanisms underlying this observation remain poorly understood. In this study, the investigators aim to study the brain mechanisms underlying the effect of intragastric administration of one specific FODMAP (fructans) on gastrointestinal and non- gastrointestinal symptom responses, changes in gut physiology(morphology of the gut, water content and intestinal motility), and to relate the findings to changes in gastrointestinal peptides. Intragastric administration of three different solutions will be given after an overnight fast: one FODMAP solution (fructans), a positive control (glucose) and a negative control (saline). The whole procedure consists of a functional magnetic resonance imaging (fMRI) and abdominal MRI examination, and will take approximately four hours. The participants will undergo the fMRI for one hour for assessing brain activity, during which blood samples will be collected. The abdominal MRI will be performed at 1-hour interval for three hours to assess pre and post stimulated changes in gut physiology, specifically the morphology of the gut water content and pan-intestinal motility. During the whole procedure, questionnaires for assessing the gastrointestinal symptoms and emotional state will be collected. The investigators hypothesise that fructans induce distension and increased sensations of pain, cramps and flatulence in the IBS group more than the HC. Furthermore, this will be associated with increased activation of pain-responsive brain regions in IBS compared to HC, which will be mediated by differential changes in gut peptide levels (↓ in orexigenic and ↑ in anorexigenic hormones).

Conditions

• Irritable Bowel Syndrome

Interventions

DIETARY_SUPPLEMENT

Fructans

500ml 0.9% normal saline containing 40g fructans

DIETARY_SUPPLEMENT

Glucose

500ml 0.9% normal saline containing 40g glucose

DIETARY_SUPPLEMENT

Saline

500ml 0.9% normal saline

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Jan Tack, MD, PHD · UZ Leuven / KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-22

Primary Completion

2019-08-10

Completion

2019-08-10

Countries

• Belgium

Study Locations